(252 days)
Not Found
No
The document describes a standard medical device (IV administration sets) and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the delivery of fluids into a patient's vascular system, which is a therapeutic intervention for various medical conditions.
No
Explanation: The device is described as an IV administration set for delivering fluids, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like insertion spikes, drip chambers, tubing, and luer connections, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "delivery of fluids from a container into a patient's vascular system." This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description focuses on the components and function of delivering fluids intravenously. There is no mention of analyzing samples from the body or providing diagnostic information.
- Lack of Diagnostic Elements: The description does not include any elements typically associated with IVDs, such as reagents, assays, or the analysis of biological samples.
IVDs are devices used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnostic, monitoring, or screening purposes. This device's function is to administer substances into the body, not to analyze substances from the body.
N/A
Intended Use / Indications for Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
IV Administration Sets are single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system
Indicated Patient Age Range
any patient population
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance bench tests were performed:
• Luer Compliance
• Priming Test / Air Visualization
• Flow rate and occlusion
• Positive pressure test
• Dynamic Tensile test
• Static Tensile test
The following performance standards were utilized in evaluating the functionality of the IV Administration Sets:
ISO 594-1:1986, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements"
ISO 594-2:1998, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"
Tests - Luer Compliance
ISO 8536-4:2010/Amd. 1: 2013, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"
Tests - Flow Rate, Positive Pressure, Negative Pressure and Static Tensile
ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Tests - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Material Mediated Rabbit Pyrogen and Characterization of Leachables
The following additional tests were also performed: Dynamic Tensile, Priming, Air Bubble Visualization and Low Pressure Occlusion.
A risk assessment was performed with no additional risks and no change to the risk profile identified. Non clinical testing performed on the predicate device was completed with the proposed IV Administration Sets to demonstrate equivalence. Results of testing show that the proposed devices meet the same performance specifications and are substantially equivalent to the predicate device. The fundamental technology of the proposed sets is unchanged when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 22, 2019
B. Braun Medical Inc. Nancy Skocypec Associate Director, Regulatory Affairs 901 Macon Blvd Allentown, Pennsylvania 18109
Re: K170595
Trade/Device Name: IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: February 24, 2017 Received: February 28, 2017
Dear Nancy Skocypec:
This letter corrects our substantially equivalent letter of November 7, 2017.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Alan M. Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170595
Device Name
IV Administration Sets
Indications for Use (Describe)
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
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3
B. Braun Medical Inc. 510(k) Premarket Notification IV Administration Sets
510(k) SUMMARY
| DATE: | November 2, 2017 |
|---|---|
| SUBMITTER: | B. Braun Medical Inc. |
| 901 Marcon Boulevard | |
| Allentown, PA 18109-9341 | |
| Contact: Nancy Skocypec | |
| Phone: (610) 596-2798 | |
| Fax: (610) 266-4962 | |
| E-mail: nancy.skocypec@bbraun.com | |
| DEVICE NAME: | IV Administration Sets |
| COMMON NAME: | IV Administration Sets |
| CLASSIFICATION: | Class II, Product Code FPA, 21 CFR 880.5440 |
| PREDICATE DEVICE: | IV Administration Set with Hand Pump, B. Braun Medical, Inc. |
| K140838, Class II, FPA, 21 CFR 880.5440 |
Description
IV Administration Sets are single use, disposable, intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components which are broadly used throughout industry including insertion spike, drip chamber, clamp, luer access device, check valve, stopcock, manifold, tubing, luer connections (connector, adaptor), and filter. IV Administration sets are configured to ensure the intended use of the device is met. The proposed device, IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system.
Indications for Use
The IV Administration Sets are intravenous administration sets intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Substantial Equivalence
Predicate Device – IV Administration Sets with Hand Pump (K140838)
The IV Administration Sets presented in this submission have the same indications for use, the same intended use, the same principle of operation and the same fundamental scientific technology as the predicate device. They are comprised of the same component types, and meet the same relevant performance specifications as the predicate devices.
4
B. Braun Medical Inc.
510(k) Premarket Notification IV Administration Sets
| Feature | Proposed Device | Predicate Device (K140838) |
|---|---|---|
| IV Administration Sets | IV Administration Sets with Hand Pump | |
| Manufacturer | B. Braun Medical Inc. | B. Braun Medical Inc. |
| Intended Use | Delivery of fluids from a container into a | |
| patient's vascular system | Delivery of fluids from a container into a | |
| patient's vascular system | ||
| Indications for Use | The IV Administration Sets are | |
| intravenous administration sets intended | ||
| for delivery of fluids from a container into | ||
| a patient's vascular system. These devices | ||
| may be used for any patient population | ||
| with consideration given to adequacy of | ||
| vascular anatomy and appropriateness for | ||
| the solution being infused and duration of | ||
| therapy. | The IV Administration Sets with Hand | |
| Pump are intravenous administration sets | ||
| intended for delivery of fluids from a | ||
| container into a patient's vascular system. | ||
| When the hand pump component is | ||
| activated, the device is intended to deliver | ||
| only crystalloid and colloid resuscitative | ||
| fluids. These devices may be used for any | ||
| patient population with consideration given | ||
| to adequacy of vascular anatomy and | ||
| appropriateness for the solution being | ||
| infused and duration of therapy. | ||
| Mode of Fluid Delivery | Gravity Administration | Gravity and/or rapidly through Hand Pump |
| Activation | ||
| Sets configured with various industry | Sets configured with various industry | |
| standard components including: | standard components including: | |
| insertion spike | insertion spike | |
| drip chamber | drip chamber | |
| tubing | tubing | |
| Administration Set | luer connections (connector/adaptor) | luer connections (connector/adaptor) |
| Components | manifold | manifold |
| needleless luer access device | needleless luer access device | |
| stopcocks | stopcocks | |
| clamps | clamps | |
| check valve | check valve | |
| hand pump | ||
| The following performance bench tests | The following performance bench tests | |
| were performed: | were performed: | |
| Summary of nonclinical | • Luer Compliance | • Luer Compliance |
| tests for determination | • Priming Test / Air Visualization | • Priming Test / Air Visualization |
| of substantial | • Flow rate and occlusion | • Flow rate and occlusion |
| equivalence | • Positive pressure test | • Positive pressure test |
| • Dynamic Tensile test | • Dynamic Tensile test | |
| • Static Tensile test | ||
| Fluid Contacting | Externally communicating blood path | Externally communicating blood path |
| Materials | indirect prolonged contact | indirect prolonged contact |
| Materials meet biocompatibility | Materials meet biocompatibility | |
| requirements per ISO 10993-1: | requirements per ISO 10993-1: | |
| Cytotoxicity | Cytotoxicity | |
| Materials and | Sensitization | Sensitization |
| Biocompatibility | Intracutaneous reactivity | Intracutaneous reactivity |
| Systemic toxicity | Systemic toxicity | |
| Hemolysis | Hemolysis | |
| Rabbit pyrogen | Rabbit pyrogen | |
| Characterization of leachables | Characterization of leachables | |
| Sterilization | Ethylene Oxide. SAL 10-6 | Ethylene Oxide. SAL 10-6 |
5
B. Braun Medical Inc. 510(k) Premarket Notification IV Administration Sets
Non Clinical Performance Testing
The following performance standards were utilized in evaluating the functionality of the IV Administration Sets. The performance bench tests conducted are listed under the applicable standard.
Standard
ISO 594-1:1986, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements"
ISO 594-2:1998, "Conical fittings with a 6% (luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings"
Tests - Luer Compliance
Standard
ISO 8536-4:2010/Amd. 1: 2013, "Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed"
Tests - Flow Rate, Positive Pressure, Negative Pressure and Static Tensile
Standard
ISO 10993-1:2009, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
Tests - Cytotoxicity, Sensitization, Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Material Mediated Rabbit Pyrogen and Characterization of Leachables
The following additional tests were also performed: Dynamic Tensile, Priming, Air Bubble Visualization and Low Pressure Occlusion.
A risk assessment was performed with no additional risks and no change to the risk profile identified. Non clinical testing performed on the predicate device was completed with the proposed IV Administration Sets to demonstrate equivalence. Results of testing show that the proposed devices meet the same performance specifications and are substantially equivalent to the predicate device. The fundamental technology of the proposed sets is unchanged when compared to the predicate device.
CONCLUSION
The results of performance and biocompatibility testing along with the same intended use, and similar indications for use and technological characteristics demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device.